Glaxo-Theravance Lung Drug Gains Backing of FDA Advisers

April 17 (Bloomberg) -- GlaxoSmithKline Plc and Theravance
Inc.’s Breo Ellipta should be approved to treat a lung disorder
that is the third-leading cause of death in the U.S., advisers
to the Food and Drug Administration said.

The companies provided substantial evidence the dry powder
inhaler can treat airflow obstruction long-term and reduce
exacerbations of chronic obstructive pulmonary disease, a panel
of FDA advisers voted today in Silver Spring, Maryland. The
agency is expected to decide whether to approve Breo by May 12.

Chronic obstructive pulmonary disease, often caused by
cigarette smoking, is an umbrella term for emphysema and chronic
bronchitis. Breo would compete with similar twice-daily products
Advair, from Glaxo, and Symbicort, from AstraZeneca Plc.

“Looking at the risk/benefit analysis of this, benefit
won,” James Tracy, a panel member who is an assistant clinical
professor of internal medicine at Creighton University School of
Medicine in Omaha, Nebraska, said during the hearing.

The drug may generate $1.3 billion in sales for London-based Glaxo in 2018, the average of five analysts’ estimates
compiled by Bloomberg. South San Francisco, California-based
Theravance would receive royalties of 15 percent on the first $3
billion of sales and 5 percent on any sales higher, the
company’s chief executive officer, Rick Winningham, said in an
interview last month.

Glaxo is Theravance’s largest shareholder, owning 27
percent of the company’s shares, according to data compiled by
Bloomberg. Theravance shares were halted today for the advisory
panel meeting. Glaxo rose less than 1 percent to 1,607 pence at
the close of London trading.

Side Effects

Breo is a combination of the compound vilanterol and a
corticosteroid. Breo and similar combinations carry side
effects, including pneumonia and increased risk of fractures,
FDA staff said in a report April 15. FDA staff questioned
whether the benefit of Breo, which it called evidence of “less
than robust” against vilanterol alone to relax the airways,
outweighed the side effects.

Panel members said patients with severe cases of chronic
obstructive pulmonary disease who would use the drug would
benefit despite the risks.

The panel voted 9-4 Breo should be approved to treat
airflow obstruction associated with chronic obstructive
pulmonary disease and to reduce exacerbations of the disorder.
Advisers also voted 10-3 that Glaxo and Theravance demonstrated
the safety of the drug.

Asthma Study

A once-daily formulation has better compliance than drugs
that must be used more often, Winningham said. Breo would be the
first drug to market produced by a Glaxo and Theravance
partnership formed more than 10 years ago, he said.

Glaxo should complete this year a study on Breo’s use in
asthma that may enable the companies to file an application for
review with the FDA for that indication, Winningham said. The
companies also are working on another treatment for chronic
obstructive pulmonary disease, called Anoro. That once-daily
medicine combines vilanterol with another ingredient to improve
lung function.

The FDA is expected to decide whether to approve Anoro in
December. The drug would compete with Pfizer Inc.’s and
Boehringer Ingelheim’s Spiriva.

Theravance generated $136 million in revenue last year
while sales are projected to almost triple to $372 million in
2016, according to the average of six analysts’ estimates.